Abstract
Background
Lumbar puncture (LP) is an essential diagnostic procedure in neurology, but carries risk, with post-lumbar puncture headache being the most frequent complication. In 2017, a severe complication with intracranial haemorrhage following LP in Northern Norway led to an evaluation of LP procedures and resulted in the development of a new unified regional procedure.
Local problem
At the University Hospital of North Norway (UNN), 10% of LPs performed in 2017 resulted in a complication. A survey identified gaps in protocol adherence, physician training, and patient education.
Intervention
Aiming to reduce LP complication rates from 10% to 1% by January 2019, we implemented standardised protocols, introduced smaller gauge needles, enhanced physician training and improved patient education.
Results
Complication rates dropped to 1%, achieving 107 consecutive complication-free procedures by January 2019, with sustained improvement over subsequent years.
Conclusion
Standardised protocols, physician training, introduction of smaller gauge needles and patient education significantly reduced LP complications. Educating patients on expectations and post-procedure care was critical in preventing unnecessary admissions and outpatient visits.
Keywords: PDSA, Quality improvement, Statistical process control
WHAT IS ALREADY KNOWN ON THIS TOPIC
Lumbar puncture (LP) is a commonly performed diagnostic procedure in neurology. While generally regarded as safe, complications like post-LP headaches occur in 20%–35% of cases. Severe complications, including infections, intracranial bleeding and spinal haematomas, are rare but carry risks of severe sequelae for patients.
WHAT THIS STUDY ADDS
This study identified a 10% complication rate for LPs within a single department, highlighting the need for improvement. A comprehensive quality improvement initiative was implemented, involving updated procedures, including the use of thinner needles, standardised documentation, enhanced physician training and patient education. These efforts resulted in a sustained reduction in complications, decreasing the rate from 10% to 1% over several years.
HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY
Our findings demonstrate that a multidisciplinary approach can substantially reduce complications associated with LPs, underscoring the importance of standardised procedures, rigorous staff training and patient education for improving procedural safety. Additionally, it highlights the need for ongoing monitoring and further research to evaluate the sustainability and long-term effects of such interventions, potentially informing future guidelines and policies aimed at enhancing procedural safety in healthcare.
Problem
Lumbar puncture (LP) is a routine diagnostic procedure in neurology. LP allows for the collection of cerebrospinal fluid, which can be analysed to diagnose a variety of neurological conditions, such as infections (eg, meningitis), inflammatory diseases (eg, multiple sclerosis), malignancies and subarachnoid haemorrhage. LP is also used to measure intracranial pressure, aiding in the diagnosis of conditions like idiopathic intracranial hypertension. Additionally, it can be used therapeutically to relieve pressure in certain conditions. Overall, LP provides critical information that can guide diagnosis and treatment decisions in neurological practice. In the Neurology Department at the University Hospital of North Norway, more than 150 LPs are performed annually. Figure 1 illustrates the procedure. In 2017, an intracranial haemorrhage post-LP highlighted safety concerns,1 particularly for patients on anticoagulants.2 A review of patient records coded with the Norwegian clinical medical procedure code for LP (ABFX01) in the hospital’s electronic health records revealed inconsistencies in protocol adherence, gaps in staff training and inadequate patient education. Moreover, the review identified a 10% complication rate following LPs at the University Hospital of North Norway, with all complications attributed to post-lumbar puncture headache (PLPH).
Figure 1. The figure illustrates the lower lumbar vertebrae (L2–L5), which represent the typical anatomical region used for performing a lumbar puncture. The procedure is usually carried out between the L3–L4 or L4–L5 intervertebral spaces, as this is below the termination of the spinal cord (conus medullaris), thereby minimising the risk of neural injury. A 25G needle is inserted through the intervertebral space into the subarachnoid space, allowing access to cerebrospinal fluid (CSF). A sample of CSF can then be collected for diagnostic or therapeutic purposes.
Specific aims
To reduce PLPH rates from 10% to 1% by January 2019 and achieve 100 consecutive complication-free procedures.
Background
Although the most feared complications of LP, such as infections, intracranial bleeding and spinal haematomas, are rare, they confer a risk of severe sequelae for patients. PLPH represents the most common complication following LP, often resulting from cerebrospinal fluid leakage.3 This type of headache typically worsens when the patient is in an upright position and is alleviated when lying down in a horizontal position. The rates of PLPH complications following LP vary widely from 32% to 46%, influenced by factors like needle size, type and insertion technique.3,5
Studies demonstrate that atraumatic needles reduce PLPH rates by as much as 50%,5,9 while effective physician training improves patient outcomes.10
Standardising procedures and enhancing patient education are critical for reducing complications and improving satisfaction.11,13
Rationale
The identified gaps indicated a need for standardised procedures, evidence-based needle selection, improved training and comprehensive patient education to minimise complications and improve outcomes.
Measurement
Context
The Department of Neurology at the University Hospital of North Norway (UNN) serves a population of ~2 00 000 inhabitants and performs around 150 LPs annually. Prior to this project, we experienced a 10% post-LP complication rate, often requiring hospitalisation. Our department, comprising approximately 25 specialists and trainees, provided a robust foundation for implementing standardised interventions.
Measures
Outcome measure: incidence of PLPHs defined as patients with a registered contact at the Department of Neurology at UNN Tromsø coded as ICD10 G97.0 (cerebrospinal fluid leak from spinal puncture).
Process measures: compliance with protocols, needle size usage and Plan-Do-Study-Act (PDSA) cycle completion.
Balancing measure: patient satisfaction.
Analysis
Data analysis and visualisation were performed using LifeQI (Life QI Limited, Exeter, UK) and Microsoft Excel (Microsoft Corporation, Redmond, Washington, USA). SPC (Statistical Process Control) charts were employed to track and analyse changes in complication rates, providing a dynamic view of process stability and improvement over time. Using the LifeQI platform,14 we designed PDSA cycles efficiently, allowing for streamlined adjustments, measurements and scaling of interventions.
Both a run chart and a G-chart were used to monitor procedure-related complications. The run chart served as the primary tool for visualising overall trends, while the G-chart specifically monitored the number of procedures between complications throughout the study period. Figure 2 illustrates the G-chart. G-charts are particularly suitable for analysing rare events, as they plot the number of opportunities (procedures) between individual occurrences of a defined event (complications).
Figure 2. The graph displays the number of procedures since the last complication over time, with the timeline divided into three phases. Pre-project phase (2017 to 1H 2018)/baseline: represented by a blue background, this phase shows fewer procedures between complications and narrow control limits, indicating a relatively stable number of procedures per complication (approximately 10:1 ratio). Project phase (2H 2018 to January 2019): marked in orange background, this phase reflects moderate improvement, with wider control limits as interventions were implemented. Sustain phase (January 2019 onwards–): shown in green, this phase demonstrates marked improvement, with a higher mean. The control limits are wide, indicating a marked improvement beyond expected variation. The dashed lines represent the average number of procedures for each phase. Blue line: number of procedures performed until a complication occurs. The date line corresponds with the date of each registered complication. The orange and green lines indicate the upper and lower control limits (UCL and LCL) for each phase. They show the range of variation and help identify deviations from expected performance.
The data were divided into three phases: baseline (January 2017 to mid-2018), project phase (mid-2018 to January 2019) and sustain phase (January 2019 onwards). For each phase, the mean number of procedures between complications was calculated, and corresponding upper and lower control limits (UCL and LCL) were determined. Changes in the mean and in the width of the control limits (CLs) were used to assess process improvement and stability over time.
Annotations marked critical points such as the start of each PDSA cycle, key interventions and specific complication instances. These visual markers created an intuitive timeline, making it easier to see how changes impacted complication rates. The chart’s elements, including the median and CLs, were instrumental in distinguishing normal process variation from significant deviations, providing a clearer evaluation of each intervention’s effectiveness. The median line, calculated from baseline data, served as a stable reference point, allowing straightforward comparisons to assess if complication rates increased, decreased or stabilised postintervention. This approach, favouring the median over the mean, helped minimise the influence of outliers, yielding a robust central measure.
CLs, calculated at key project stages, establish an expected range of variation, typically set at ±3 SD from the median. Values outside these limits indicated special-cause variation, signalling that factors beyond routine fluctuations were impacting the process. This approach effectively highlighted statistically significant impacts from interventions, differentiating real improvements from random variations.
Design
Interventions
Interventions were structured and tested through iterative PDSA cycles. The unified procedure is enclosed in online supplemental appendix 1. Interventions included:
Standardised LP protocols: a comprehensive LP checklist and a pocket-sized procedural guide (both in online supplemental appendix 2), and a standardised journal note template for documentation of the procedure in the patients’ electronic health record (online supplemental appendix 3) were developed. The procedure outlined relevant contraindications and best practice recommendations to promote consistent and safe LP procedures. Five PDSA cycles shaped the pocket-sized guide’s design and integration. In cycle 1, one physician trialled the guide, providing feedback for initial revisions. Subsequent cycles expanded its use from three to all interested doctors, eventually embedding it into the department’s orientation for new hires. The journal note template required only two cycles, benefiting from the foundational standardisation achieved through the checklist
Needle size selection: based on evidence supporting thinner needles to reduce PLPHs, a transition to thinner needles was implemented. Each size adjustment involved one PDSA cycle, confirming safety and efficacy before moving to the next phase. The predefined aim, to reduce PLPH rates from 10% to 1%, was achieved by the use of 25-gauge traumatic needles during the third PDSA cycle. The decision to use thinner traumatic needles, and not move directly to atraumatic ones, was driven by several practical considerations. Thinner traumatic needles allowed for easier insertion, particularly for practitioners already familiar with their use, reducing the need for extensive retraining or introducing entirely new procedures. Our approach enabled a gradual transition to smaller needle sizes, allowing for incremental adjustments rather than an abrupt shift in practice. Additionally, the results achieved with thinner traumatic needles while maintaining procedural efficiency were highly satisfying. This balance of familiarity, ease of use and positive outcomes made the choice both practical and effective.
Physician training: targeted training sessions were introduced to reinforce the use of thinner sized needles, adherence to protocols and application of the new standardised LP guidelines. Training sessions were delivered to all physicians with adjustments based on feedback, ensuring widespread competency and protocol adherence.
Patient education: a structured patient education protocol (online supplemental appendix 4) was developed, combining written and verbal information about post-LP expectations, especially headache management and other potential complications. Patient feedback informed adjustments to the materials, which were refined to be accessible and reassuring, increasing patient confidence and compliance.
Strategy
Key learning points from each PDSA cycle informed subsequent cycles. Initial resistance was addressed through clear communication and phased implementation. Feedback from patients and physicians refined materials and protocols, ensuring alignment with clinical needs. The team held regular meetings to review progress, address challenges and ensure alignment with project goals.
Results
From March 2018 to January 2019, a total of 184 LPs were performed, with complication rates reduced from 10% to <1%, achieving 107 consecutive complication-free procedures. SPC charts highlighted sustained improvements, with complication rates declining further to 0.82% by 2022. Contextual factors, such as consistent training and patient feedback, contributed to the interventions.
The G-chart (figure 2) tracks performance across three key phases: pre-project, project phase and sustain phase, each with its own calculated mean, UCL and LCL. CLs are set at ±3σ from the mean in each phase, highlighting both normal process variation and the improvements postintervention. The data reveal a clear shift in performance, particularly during the sustain phase, showing that these changes have led to lasting benefits. By 2021, the complication rate had decreased to 0.99%, dropping further to 0.82% in 2022, indicating sustained improvement and a stable, reliable process since 2019 (figure 3).
Figure 3. The chart shows the number of procedures performed and the number of complications for each year from 2017 to 2024.
Lessons and limitations
Summary
This quality improvement initiative successfully reduced PLPH rates from 10% to 1%, driven by the implementation of standardised protocols, introduction of thinner needle sizes, targeted physician training and comprehensive patient education. Educating patients on what to expect before and after the procedure, and when to seek medical help, ensures that patients are psychologically prepared to manage minor symptoms more effectively. While it remains to be conclusively determined whether education directly reduces the rate of complications such as PLPH or primarily helps patients cope better with expected side effects, this approach may contribute to fewer re-admissions by fostering realistic expectations and empowering patients to manage symptoms at home. Additionally, symbolic milestones, such as recognising the first 100 complication-free procedures, reinforced the department’s achievements and motivated ongoing effort.
Interpretation
Key factors in the reduced complication rates included the adoption of thinner needles and standardised protocols. Patient education played a vital role in enabling proactive recovery management. This combination of technical improvements and patient engagement was crucial to reducing complications and enhancing satisfaction. Unfortunately, our integrated approach and design make it difficult to pinpoint the relative impact of individual components of our QI project. However, we believe all to be important factors in achieving our aim. Further, the project demonstrates the importance of continuous feedback loops and milestone recognition, which motivate staff adherence to updated procedures. The iterative process allows for testing and adapting new ideas quickly, fostering a culture of continuous improvement. Flexibility in responding to real-time data is essential for sustaining positive outcomes.
Limitations and challenges
Despite its success, the project encountered challenges. Physician resistance to altering existing protocols and the challenge of providing consistent training within our department slowed the implementation process. Additionally, the small sample size and potential biases from self-reported data limit the generalisability of the findings. These factors, along with the specific context of the project, suggest caution when applying these results to other settings. Moreover, the lack of a structured follow-up of all LP patients may have resulted in a falsely low complication rate, while it also precluded the quantification of the effect of patient education on the outcome measure.
Why PDSA?
The PDSA methodology was selected for its structured yet adaptable framework, enabling small-scale testing and iterative refinement before broader implementation. This approach supports rapid adjustments, valuable in situations with uncertain outcomes. PDSA does have its limitations. It can extend timelines compared with more direct strategies, potentially posing challenges when swift action is required. Additionally, its effectiveness is often greatest in controlled, smaller-scale settings, necessitating multiple cycles to gather enough evidence for large-scale adoption. The methodology’s reliance on qualitative feedback, while invaluable for early-stage insights, may fall short in delivering the detailed statistical analyses needed for complex or precision-dependent environments. PDSA was deemed fitting for this project due to its capacity for gradual, evidence-based improvement and its focus on motivation and engagement.
Conclusion
This quality improvement project effectively addressed critical safety concerns surrounding LP procedures at the Department of Neurology, University Hospital of North Norway. By systematically implementing standardised protocols, transitioning to thinner needles, delivering targeted physician training and educating patients, we achieved a significant reduction in PLPH rates from 10% to 1% by January 2019. Notably, the project reached its goal of 100 consecutive complication-free procedures, demonstrating a substantial enhancement in patient care and safety, as confirmed through rigorous SPC analysis.
The initiative was guided by the PDSA methodology, which enabled iterative testing, refinement and adaptation of interventions to meet evolving needs. The success of the project was underpinned by evidence-based practices, including the adoption of thinner needles and comprehensive patient education, combined with continuous feedback loops and active staff engagement. The PDSA framework’s structured yet flexible nature facilitated real-time responses to challenges, ensuring the long-term sustainability of improvements.
While the project achieved its objectives, challenges arose, including initial resistance to change and logistical hurdles in standardising training across a busy department. These obstacles were mitigated through clear communication, phased implementation strategies and the recognition of milestones, fostering motivation and alignment among staff. However, limitations such as the small sample size and reliance on self-reported data suggest the need for further studies in larger and more diverse settings to validate the findings and support broader applicability.
Financially, the project delivered measurable value by reducing hospitalisations related to complications, thereby lowering associated costs, and improving patient outcomes. Sustained reductions in complication rates—declining further to 0.82% by 2022—illustrate the lasting impact of the interventions and their potential for replication in similar healthcare environments.
Moving forward, ongoing monitoring as well as continued education and training will be essential to maintain adherence to protocols and identify opportunities for further enhancement. The integration of digital tools for training and patient education represents a promising avenue for continued improvement. Additional research should (1) explore the application of these interventions in diverse clinical contexts to assess scalability and refine approaches for widespread implementation and (2) quantify the relative impact of each component of the improvement initiative with a special focus on needle size selection and patient education.
This project underscores the transformative potential of structured quality improvement methodologies in healthcare. It highlights the ability to achieve meaningful, sustainable outcomes while fostering a culture of continuous improvement and collaboration within clinical settings.
Supplementary material
Acknowledgements
The success of this project would not have been possible without the dedication and collaborative efforts of the entire team at the Neurology Department, University Hospital of North Norway. Every team member contributed significantly to the process of implementing standardised protocols to ensure comprehensive patient education and training. Their commitment to continuous improvement and patient safety was instrumental in achieving the project’s goals. Thank you to all who played a role in this transformative initiative.
Footnotes
Funding: The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Provenance and peer review: Not commissioned; externally peer reviewed.
Patient consent for publication: Not applicable.
Data availability free text: All procedures developed during the QI project have been made available in online appendices. Outcome data are available upon reasonable request.
Patient and public involvement: Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Data availability statement
Data are available upon reasonable request.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data Availability Statement
Data are available upon reasonable request.